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Individual e-Learning



Fundamentals and Essentials of Validation

Time and cost-saving strategies for pharmaceutical and active pharmaceutical ingredient manufacturers

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Benefits of attending for you and your company

At the end of the course you will...

understand how validation can save the company money and help rapidly bring products to market

be acutely aware of what specifics the regulatory authorities deem key to effective validation

know the pitfalls of validation and how to avoid them

be knowledgeable in all aspects of the validation process

appreciate the complexity of validation and the contribution various disciplines can bring to ensuring validation is completed efficiently and cost effectively

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Who Should Attend

This course is intended for quality assurance, engineering, production, quality control and product development personnel who are all intimately involved in the validation effort. This course will be of special interest to all managers trying to establish a cost-effective approach to organizing the validation effort and to those personnel responsible for performing validation.

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Course Langauge


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Course Overview

Validation has become the most complex, costly and time-consuming aspect of all the activities a healthcare manufacturing company must perform in order to comply with good manufacturing practices (GMP). Why do we do it? What are the benefits? How can we do it cost-effectively and efficiently?
Regulatory authorities, in their effort to protect the health and safety of patients, insist that validation be performed in all areas of product development, production and quality control testing. This course covers all the elements of the five key validations required by manufacturers to satisfy regulatory authorities (including the United States FDA): process validation, cleaning validation, utilities validation, computer validation and analytical method validation.

The course presents the four qualification phases of validation (DQ, IQ, OQ, and PQ) and the five different validations in a logical and organized manner. The course describes exactly what is required to be performed, how to plan for validation and who in the company should carry out which aspects of the validation exercise. Drawing on worldwide experience in validation activities, the course presents examples of companies performing validation right and companies performing validation wrong. Validation, efficiently managed, provides significant benefits and cost savings to companies, in addition to allowing speedy product and facility approval during government inspections.

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Course Outline

Overview and background

What is validation? Why is it required? What are the regulations, international regulatory requirements (United States FDA, European Union, Japan, ISO-9000) and industry trends? The cost of validation.

Concepts and terms

Definitions and requirements of: metrology (calibration), protocols, design qualification, installation qualification, operational qualification, performance qualification, validation, recovery testing, validation master plan, retrospective validation, concurrent validation, prospective validation, acceptance criteria, validation summaries, reports and life cycles.

Process validation

Requirements and techniques involved with validation of:
— Active pharmaceutical ingredients (APIs)
— Pharmaceuticals (sterile and non-sterile)
— Biotechnology products

Cleaning validation

How clean is clean? Cleaning validation requirements; cleaning validation methodology; recovery testing techniques; calculating cleaning limits (MACO, MARS).

Analytical method validation

The seven essential elements of analytical method validation: accuracy, precision, selectivity, specificity, linearity, limits of detection, limits of quantitation and ruggedness. The role of research and development in validation. Technology transfer documents and development reports. Laboratory equipment qualification.

Utilities validation

Validation of: air conditioning (HVAC) systems, compressed air systems, purified water and water for injection systems, steam systems, electrical and gas systems.

Computer validation and 21CFR Part 11 Compliance (electronic records)
  When is a computer a computer, and when does it need validating? Validation of computer hardware (personal computers, PLCs, etc.); software validation. Approaches to validating commercially available software and in-company developed software. Software validation development life cycles; international standards for software validation; 21CFR11 compliance issues. Where exactly is FDA in its requirements for compliance with the electronic record/signature regulations (21CFR11)?
Case study

Work in groups to develop an FDA acceptable validation study: DQ/IQ/OQ/PQ — the lot.

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Previous Participant Testimonials

I just wanted to drop you a line to say thank you for a very useful and
interesting seminar. I know that my company got the most bang for their buck with all the questions that you answered for me. It was a pleasure... and the lunches were great!
Melanie Cerullo

Thank you for a great course and your insight over the past 2 days! I wish I could have spent more time really asking further in depth question but time and travel intervened. Thanks again.
H. Kriss, SIAL


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